Healthy Skepticism Library item: 273
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Picard A.
Antidepressant users require monitoring, U.S. agency says
The Globe and Mail 2004 Mar 23
Full text:
Everyone who takes a popular class of antidepressants should be monitored because they may be at increased risk of suicide, U.S. drug regulators are warning.
The public-health advisory raises, by yet another notch, the growing concerns over a class of medications that are among the biggest sellers in the world.
The U.S. Food and Drug Administration said yesterday that physicians, caregivers and family members should closely monitor both adults and children taking antidepressants, particularly when they are newly prescribed, or when dosage changes.
The FDA also ordered the manufacturers of 10 big-selling drugs to alter their warning labels to warn of a possible increase in suicidal thoughts and behaviours by people taking these prescription drugs.
Emmanuel Chabot, a spokesman for Health Canada, said the regulator has no immediate plans to order label changes in this country because “this issue has already been dealt with in the product monograph,” which is intended to provide factual information about a drug, including its indications and potential side effects.
But he said the concerns expressed by the FDA “will be taken into consideration during our ongoing review of antidepressants and, if there are additional concerns, Health Canada will take the necessary measures to protect the health of Canadians.”
In its advisory, the FDA ordered that the warning labels be included on all antidepressants from two closely related classes of drugs, selective serotonin re-uptake inhibitors and serotonin noradrenaline re-uptake inhibitors.
The drugs targeted include: Prozac, a product of Eli Lilly; Paxil and Wellbutrin, both by GlaxoSmithKline; Zoloft, by Pfizer; Effexor, by Wyeth; Celexa and Lexapro, both by Forest Laboratories; Remeron, by Akzo Nobel; Luvox, by Solvay Pharmaceuticals; and Serzone, by Bristol-Myers Squibb.
(Lexapro is not sold in Canada and Serzone has been withdrawn from the Canadian market.)
In its release, the FDA stressed that is it unclear whether taking these drugs actually increases a person’s risk of suicide, noting that depression itself is a leading cause of suicide. But the regulatory agency said that, until the issue is resolved, more monitoring is advisable.
The safety of antidepressants, and SSRIs in particular, has been a topic of heated debate for a number of years.
It is an issue that has potentially large medical and economic implications because antidepressants are among the most prescribed drugs in Canada, and also among the most lucrative for pharmaceutical companies.
According to IMS Canada, a company that tracks prescription-drug trends, there were 15.7 million prescriptions last year for SSRIs and sales topped $990-million. Paxil alone has sales of more than $280-million a year.
Scientists, led by British researcher David Healy, have studied the suicide-antidepressant link for a number of years. But British health authorities brought the issue to the fore last year, saying long-suppressed research suggested certain antidepressants can increase the risk of suicidal behaviour in children and teenagers.
Britain declared many SSRIs unsuitable for young people.
The U.S. FDA followed suit with a caution on pediatric use last year and it is currently holding public hearings on the issue.
Earlier this year, Health Canada issued its own public-health warning about seven SSRIs. It said that all Canadians under the age of 18 who are taking one of the suspect prescription drugs should immediately “consult their treating physician to confirm that the benefits of the drug still outweigh its potential risks.”
There are no antidepressants approved specifically for use in children and teenagers, but they are routinely prescribed for so-called “off-label” use.
